QA Investigator & CAPA Specialist

Regulatory Jobs; Gurabo (PR); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

ASQ Certified QA Auditor

Job summary

Johnson & Johnson in Gurabo, Puerto Rico is seeking a QA Specialist—Investigations & CAPA to maintain the Quality System in line with GMP and corporate SOPs. You will manage investigations, CAPA and related documentation, ensuring compliant closure of issues.

Role requires experience in pharma QA, ability to work cross-functionally in a bilingual environment and strong written communication in English and Spanish. Knowledge of cGMP is essential.

Qualifications

• A minimum of two (2) years of experience in investigations and CAPA in the pharmaceutical industry.
• Experience with parenteral or biological manufacturing is preferred.
• Familiarity with cGMP, GxP, and international GMPs; strong written and spoken English/Spanish.

Responsibilities

• Evaluate and approve records for Quality Investigations and CAPA actions.
• Collaborate with J&J affiliates and JSC functions; coordinate investigation strategies.
• Monitor performance of QA Investigations and CAPA system and report metrics.

Skills

Business Alignment

Data Analysis

Detail-Oriented

Internal Controls

Issue Escalation

Problem Solving

Process Oriented

Quality Control

Quality Management Systems

Quality Standards

Education

Bachelor's degree in Chemistry/Biology/Biochemistry/Microbiology/Engineering/Mathematics or related science

Job description

Johnson & Johnson in Gurabo, Puerto Rico is seeking a QA Specialist—Investigations & CAPA to maintain the Quality System in line with GMP and corporate SOPs. You will manage investigations, CAPA and related documentation, ensuring compliant closure of issues.

Role requires experience in pharma QA, ability to work cross-functionally in a bilingual environment and strong written communication in English and Spanish. Knowledge of cGMP is essential.